Pharmaceutical Approval Update: Travoprost Z Ophthalmic Sterile Solution 0.004% (Travatan Z)

28 Mar
2010

Pharmaceutical Approval Update

Manufacturer: Alcon Laboratories, Inc., Fort Worth, TX Indication: Travoprost Z is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are intolerant of, or insufficiently responsive to, other IOP-lowering medications.

Drug Class: This agent is a synthetic prostaglandin F2a (PGF2a) analogue. Its chemical name is isopropyl (Z)-7-[(1 R, 2 R ,3 R ,5 S )-3,5-dihydroxy-2-[(1 E ,3 R )-3-hydroxy-4-[(a,a,a-trifluoro-m-tolyl)oxy]-1-butenyl]cyclopentyl]-5-heptenoate.

Uniqueness of Drug: The new formulation eliminates the preservative benzalkonium chloride (BAK) from Alcon’s present Travatan solution and replaces it with Sofzia, an ionic, buffered preservative system that is gentle to the ocular surface. Alcon developed this BAK-free version because the long-term use of topical solutions containing BAK was found to irritate the ocular surface and exacerbate conditions such as dry eye. (The “Z” in the agent’s name represents zero BAK.)

Warnings: Travoprost Z has been reported to cause potentially permanent changes, such as increased pigmentation of the iris and eyelashes, darkening of the periorbital tissue (eyelid skin), and increased growth of the eyelashes.

Travoprost Z may gradually result in a change in eye color by increasing the number of melanosomes in the melanocytes of the iris. The long-term effects on the melanocytes and the consequences of potential injury to the melanocytes or depo­sition of pigment granules to other areas of the eye are unknown. The change in iris color occurs slowly and may not be noticeable for months to years.

Patients should be informed of the possibility of iris color change.

Patients who are expected to receive treatment in only one eye should be informed about the potential for increased brown pigmentation of the iris, of the eyelid tissue, and of the eyelashes in the treated eye; of different eye colors; and of a disparity between the eyes in length, thickness, or number of eyelashes.

Precautions:

General. Bacterial keratitis has been associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who usually had a concurrent corneal disease or a disruption of the epithelial surface. cialis canadian pharmacy

Color Changes. Increased brown pigmentation of the iris may be more noticeable in patients with mixed colored irides (blue-brown, gray-brown, yellow-brown, or green-brown), but it has also been observed in patients with brown eyes. The color change is believed to be a result of increased melanin content in the stromal melanocytes of the iris. The exact mechanism of action is unknown.

Typically, the brown pigmentation around the pupil spreads concentrically toward the periphery in affected eyes, but the entire iris or parts of it may become more brownish. Until more information is available, patients should be examined regularly. Depending on the situation, treatment may be stopped if increased pigmentation ensues.

Ocular Conditions. Travoprost Z should be used with caution in patients with a history of intraocular inflammation (iritis or uveitis) and generally should not be used in patients with active intraocular inflammation.

Macular edema has been reported during treatment with PGF2a analogues. These reports have mainly occurred in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. Travoprost Z should be used with caution in these patients.

Travoprost Z has not been evaluated for the treatment of angle-closure glaucoma, inflammatory glaucoma, or neo-vascular glaucoma. buy generic levitra

Kidney and Liver Impairment. Travoprost Z has not been studied in patients with renal or hepatic impairment. It should be used with caution in such patients.

Contact Lenses. Travoprost Z should not be administered while the patient is wearing contact lenses. Contact lenses should be removed before the solution is administered. The lenses may be re-inserted 15 minutes following the administration of travoprost Z.

Dosage and Administration: The recommended dosage is one drop in the affected eyes once daily in the evening. The dosage should not exceed once a day, because more frequent administration may decrease the IOP-lowering effect. The reduction of IOP starts approximately two hours after administration, and the maximum effect is reached after 12 hours.

Travoprost Z may be used concomitantly with other topical ophthalmic drug products to reduce IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

Commentary: Problems affecting the ocular surface are critical variables in glaucoma management. Unfortunately, for many glaucoma patients, the chronic therapy that is helping to preserve their vision also may be causing ocular irritation and exacerbating symptoms of dry eye over time. When these problems occur, patients become non-adherent to their medical regimen, or they may self-treat with over-the-counter artificial tears.
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An abundance of evidence has identified concerns about changes to the conjunctiva and the cornea related to ophthalmic preservatives of IOP-lowering medications. Topical IOP-reducing agents containing BAK may negatively affect the success rates of glaucoma-filtration surgical procedures. The negative effects of BAK are cumulative in a long-term scenario of chronic use, such as in glaucoma therapy. The travoprost Z formulation eliminates the preservative BAK from the original travoprost solution.

Because almost 40% of glaucoma patients have ocular-surface disease, travoprost Z is an advance in therapy that should enable physicians to address an unmet need of many glaucoma patients.

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